1. Technical Field
The present invention relates to hormone treatments. More specifically, the present invention relates to testosterone treatments.
2. Background Art
Testosterone is a compound needed and produced by the body in both men and women for several different functions. It is needed for the development and maintenance of sex organs and characteristics, as well as for muscle growth, bone development, and bone maintenance. The production of testosterone is regulated by the brain through the release of hormones. Testosterone is produced in the testes, 95% and 5% in the adrenals. To stimulate its production the hypothalamus releases to the pituitary gland a gonadotropin-releasing hormone (GnRH), which, in turn, causes the pituitary to produce a follicle-stimulating hormone (FSH) and a luteinizing hormone (LH) collectively known as gonadotropins. LH is released into the blood stream and travels to the testes to trigger the production of testosterone from cholesterol (!). When the testosterone level gets too high the pituitary slows the release of LH to slow it down. The actual testosterone production occurs in the Leydig cells in the testes and adrenals in men and also in women production occurs in the ovaries and adrenals. Healthy young men produce about 6 milligrams of testosterone per day and healthy women produce 0.3 mg of testosterone per day ( 1/20th of what men produce).
While age can naturally decrease testosterone levels, many individuals suffer from lower than normal levels of testosterone. Low levels of testosterone can be caused by hypogonadism (a problem with the organs that produce testosterone, i.e. the ovaries or testes), secondary hypogonadism (a problem with regulation of testosterone), or tertiary hypogonadism (a problem with the hypothalamus). Each of these problems can be caused by a variety of factors, including aging, injury, disease, cancer therapies such as chemotherapy and radiation therapy, chromosomal abnormalities, drug use, and obesity. In particular, secondary and tertiary hypogonadism are caused by diseases that affect the hypothalamic-pituitary-gonadal axis (i.e. the system of the hypothalamus, pituitary gland, and gonads). The hypothalamus produces gonadotropin-releasing hormone (GnRH), the anterior portion of the pituitary gland produces luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and the gonads produce testosterone.
Low levels of testosterone, commensurate with high levels of cortisol, are also associated with stress, depression and other psychological disorders. This occurs through interconnections linking the components of the body in stress apparatus i.e. the nerves, hormonal glands (HPA axis) and the immune system. Other symptoms of low testosterone in men include decreased libido, infertility, erectile dysfunction, loss of hair, decreased muscle mass, osteoporosis, and, in women, include hot flashes, irritability, decreased libido, sleep disturbances, loss of muscle mass, osteoporosis, and loss of body hair. To make matters worse for aging men, many conventional antidepressant medications suppress testosterone production and thus libido. As women go through menopause, they also have many of these problems because of lower levels of testosterone.
Treatments for low testosterone currently include hormone replacement therapy (HRT or TRT—testosterone replacement therapy). Testosterone can be given to men as an intramuscular injection, patch or gel placed on the skin, or a putty applied to the gums of the mouth. Some experts suggest that testosterone replacement therapy might reduce the need for the antidepressant medications entirely. Unfortunately, there is no current treatment available for women. Some women resort to using patches available for men and cutting them to a size more appropriate of a dose for women, but this has questionable accuracy and safety.
ANDROGEL® (Abbott Laboratories) is one product on the market for TRT for men that contains synthetic testosterone, and when applied to the skin, it increases the concentration of testosterone. The dose used is 100 times as what is present in the blood. The use of ANDROGEL® can produce unwanted side effects, such as causing irritation to the skin due to the carrier used which includes many chemicals to facilitate penetration through the skin. It is also an expensive drug.
Olfaction, the sense of smell, is critical for the survival of almost all creatures. Humans are able to distinguish over 10,000 different odor molecules. With every inhalation, currents of air swirl through the nostrils over the bony turbinates in the nose that contain receptors in the olfactory epithelium. The cilia projecting from the olfactory knob contain receptors for odorants. The cilia project from the knob directly into the atmosphere. The interaction of the right molecule with the right receptor causes a structural transformation of the receptor, which gives rise to an electrical signal to the olfactory bulb and thence to the areas in the limbic brain that perceive it as the original smell.
In 2000 Shinohara, et al. published a study on the effect of androstenol on the pulsating secretion of the luteinizing hormone (LH) in human females. The subjects, female college students, had their upper lip exposed to androstenol and their pulsating frequency of LH was measured. The frequency of the pulse in the follicular phase was decreased. This is a direct proof that sniffing androstenol affects the LH pulse. In a subsequent study (Shinohara, et al. 2001) it was determined that axillary pheromones (putatively androstenol) modulated the LH of humans.
Preti, et al. (2003) showed that male axillary extracts (underarm secretions) affect the pulsating secretion of LH and the mood of the women participants in this experiment.
From these studies, it is evident that presenting human hormones through the olfactory system elicits a physiologic response.
Another study (unpublished work by Shifrine) showed that pigs fed cultured truffle powder (i.e. French truffles grown in hydroponics and on grain) in their feed exhibited improved feed efficiency, significantly lowered feed consumption, significantly lowered fat, and increased leanness of carcasses. The very low dose of 1 gram dried powdered cultured truffle per ton of feed suggested that the effect of the truffle was due through inhalation and not ingestion. This suggests a “testosterone response”. However, at the time of this study, testosterone had not been reported in scientific literature to be present in truffles. Androstenol, shown to be contained in truffles, on the other hand was isolated from pig testes by Prelog & Ruziaka (1944). It was later discovered in truffles and offered as an explanation for the ability of pigs to detect this hypogeous mushroom (Claus et al., 1981).
In 2006, Applicant discovered that, in addition to androstenol, the truffle culture produces testosterone, which might explain the ‘testosterone effect’ in pigs, and the reason truffles are reputed to have aphrodisiac potential. At the concentration of 1.7 μg of testosterone in a gram of dry weight of truffles (truffle powder, from truffles grown on grain), which is equivalent to ca. 6×1015 molecules, there are ample molecules to cover all androgen receptors in the nose. Since pigs are the best experimental animals for humans (Simon and Maibach, 2000) it is reasonable to extrapolate the data from the pig study to humans.
Therefore, there remains a need for a safe and effective method of increasing testosterone in both men and women who suffer from low levels of testosterone.